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The issuance of the registration details of new and existing chemical substances in Taiwan was delayed until 5 Dec 2014. The delay meant there were only 7 days for preparation before the actual Dec 11th 2014 implementation date. However, the Regulation on Registration of New and Existing Chemical Substances published by Taiwan EPA includes major changes compared to the draft version issued earlier on Aug 25TH. The changes concerning tonnage band, joint registration, grace period, confidentiality validity, etc. are to be specified as below.
1. Tonnage bands
Taiwan drafted four tonnage bands (Band 1:1-100t/y, Band 2:100-1000t/y, Band 3: 1000-10000t/y, and Band 4: above 10000t/y) for standard registration in August. However, in the final version of the EPA regulation, the four tonnage bands are identical to those in the EU REACH, K-REACH, China NCSN, etc. The final tonnage bands are:
Band 1: 1-10tonnes/year;
Band 2: 10-100tonnes/year;
Band 3: 100-1,000tonnes/year; and
Band 4: over 1,000tonnes/year.
The registration types are charted as below. Other than the change in tonnage bands, data requirements are raised for CMRs. As long as CMRs are manufactured or imported in quantities of over 1 ton a year, hazard and exposure assessment information should be submitted.
Chart. 1 - New Chemical Substance Registration Type under Taiwan TCSCA (Final version)
2. Joint registration
Two or more manufactures or importers applying for registration of the same new chemical substance may jointly or successively submit application for registration approval. Compared to the draft, the final version requires tonnage accumulation for joint submission, which may result in higher data requirements and thus higher costs to share in the consortium. However, different from other countries, Taiwan’s EPA set an additional clause reserving the right to modify the registration type of a new chemical substance when the total annual volume manufactured or imported nationally reaches a certain amount.
3. Transitional Measures
Chemical substances already manufactured or imported into Taiwan before 11 Dec 2014 which haven’t been listed in Taiwan’s ECSI will still have another opportunity to be appended into the ECSI. Companies can notify authorities of such chemicals until the 31st of Mar 2015 by providing evidence proving these substances have been previously manufactured or imported. If approved, the substances will be listed into Taiwan ECSI. All chemicals in the ECSI are subject to existing chemical registration.
Instead of two-year grace period outline in the August draft regulation, the final version will only grant a one-year grace period for new chemical substance manufactured/ imported from the 11th of Dec 2014 until the 31st of Dec 2015. During the grace period registrants are only required to submit materials required for low-quantity registration. When the grace period passes, new chemical substance should apply for different registration types accordingly.
4. Confidentiality Validity
Protection of registrant information, chemical identification information, manufacture/importation information and usage information can be applied for. Compared to the draft regulation which offered five years confidentiality protection for all three registration types, in the final version different validity periods are applied to different registration types, i.e. five years for standard registration, two years for simplified registration and low-volume registration.
Applicants can apply for a one-off extension of confidentiality protection three months before the expiration of protection. The validity period of an approved confidentiality protection application is a maximum of 15 years. It is 5 years longer than that granted in the draft regulation.
